Johnson & Johnson reports new data showing increased protection against Covid-19 when a booster shot of its vaccine is administered.
FDA warns the Fibromyalgia Treatment Group it is selling unapproved new drugs.
FDA approves a Samsung Bioepis and Biogen BLA for Byooviz (ranibizumab-nuna), the first biosimilar version of Genentechs age-related macular degenerat...
Federal Register notice: FDA makes available on its Web site certain final administrative orders, including for over-the-counter (OTC) drug monographs...
FDA issues an alert about the potential for false positive results with Abbott Moleculars Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP K...
AbbVie files a BLA supplement for Skyrizi (risankizumab-rzaa) for treating patients 16 years and older with moderate to severe Crohns disease.
FDA posts a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence for generic drug developers.
Medtronics Micro Therapeutics unit recalls its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to t...